Intragastric device for treating obesity

Abstract

A gastrointestinal device for treating obesity includes a three-dimensional porous structure configurable between a compressed pre-deployment configuration to facilitate delivery and an expanded post-deployment configuration. The porous structure includes a first opening at its proximal end and a larger second opening at its distal end. The porous structure also includes a sleeve coupled to its distal end. Optionally, the device further includes a suture at the proximal end of the wire mesh structure to facilitate retrieval and an anti-migration component positioned at the junction of the porous structure with the sleeve. The porous structure is deployed in a patient's stomach such that the anti-migration component sits proximal to the patient's pylorus and prevents migration of the entirety of the device into and through the pylorus. The sleeve extends through the pylorus, into the duodenum and ends in the duodenum or jejunum. Food enters the device from the first opening at the proximal end of the porous structure, passes through the porous structure and sleeve, and exits at the distal end of the sleeve. The device treats obesity by providing a relatively immovable volume occupying structure in the stomach and a bypass for food past the pylorus and proximal portion of the small intestine. Optionally, the device further acts to slow the passage of food through the digestive tract. Patients with the device experience satiety more quickly and have a prolonged sensation of satiety.

We claim: 
     
       1. A method of delivering a gastrointestinal device, using a delivery device, into a gastrointestinal tract of a patient, said gastrointestinal device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, an anti-migration collar proximate a distal end of said porous structure, and an elongate sleeve coupled to a distal end of said porous structure, said delivery device comprising a flexible outer catheter having a proximal end, a distal end, and a lumen; a flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, wherein said flexible inner catheter is positioned coaxially, and is adapted to be slidably movable, within the lumen of said outer catheter; a first handle attached to the proximal end of said inner catheter and having a proximal end, a distal end, and a lumen configured to slidably receive said guide wire; a second handle attached to the proximal end of said outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive said inner catheter, a first stopping mechanism removably attached to an exposed portion of said inner catheter; and a second stopping mechanism removably attached to said exposed portion of said inner catheter and positioned proximal to said first stopping mechanism, said method comprising the steps of:
 sliding said delivery device over a guide wire and into said gastrointestinal tract of said patient; 
 using fluoroscopy to determine a location of said distal end of said flexible outer catheter to ensure a correct positioning of said delivery device; 
 holding said first handle to keep said inner catheter in place and retracting said outer catheter to said first stopping mechanism such that the elongate sleeve is partially deployed while the porous structure and the anti-migration collar remain undeployed in the pre-deployment configuration; 
 retracting the entire delivery device until said distal end of said outer catheter is positioned just proximal to a pylorus of the patient; 
 removing said first stopping mechanism from said inner catheter; 
 holding said first handle to keep said inner catheter in place and retracting said outer catheter to said second stopping mechanism such that the anti-migration collar is fully deployed and the porous structure is partially deployed in a configuration between the pre-deployment configuration and the post-deployment configuration; 
 removing said second stopping mechanism; 
 holding said first handle to keep said inner catheter in place and retracting said outer catheter to said first handle such that the elongate sleeve and the porous structure are fully deployed in the post-deployment configuration; and 
 removing said delivery device from said patient. 
 
     
     
       2. The method of  claim 1 , wherein, when said outer catheter is retracted to said first stopping mechanism, a portion of said sleeve is delivered to, and positioned within, an intestinal portion of said patient's gastrointestinal tract. 
     
     
       3. The method of  claim 1 , wherein, when said outer catheter is retracted to said second stopping mechanism, a portion of said sleeve and a portion of said porous structure are delivered to, and positioned within, a stomach portion of said patient's gastrointestinal tract. 
     
     
       4. The method of  claim 1 , wherein, when said outer catheter is retracted to said first handle, all of said porous structure is delivered to, and positioned within, a stomach portion of said patient's gastrointestinal tract. 
     
     
       5. The method of  claim 1 , wherein, prior to delivery of said gastrointestinal device, a proximal portion of said inner catheter positioned between said first and second handles is exposed and not covered by said outer catheter. 
     
     
       6. The method of  claim 1 , wherein said delivery device further comprises an elongate flexible pilot component having a distal spherical component and a proximal spherical component and extending from said distal end of said inner catheter. 
     
     
       7. The method of  claim 6 , wherein at least one of said pilot component and said distal end of said outer catheter include a hydrophilic coating and wherein said method further comprises activating said hydrophilic coating before sliding said delivery device over said guide wire.